CFDA Registration

China Medical Device Registration China Medical Device Registration and Drug Registration

Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration

Chapter 1 General Provisions

Article 1 This Procedure is formulated for the purpose of effective prevention, timely control and elimination of the hazards of public health emergencies to ensure the health and safety of the public in accordance with the Drug Administration Law of the People’s Republic of China, Law of the People’s Republic of China on the Prevention and Treatment of Infectious Diseases, Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, Regulations on Preparedness for and Response to Emergent Public Health Hazards, and other relevant laws and regulations.

Article 2 The special review and approval procedure for drug registration refers to the procedure and requirements of the State Food and Drug Administration to carry out special review and approval of drugs for handling public heath emergencies under the principle of unified leadership, early involvement, expeditiousness and efficiency, and scientific review and approval, in an effort to approve drugs for the prevention and treatment of public health emergencies as soon as possible under the threat or after the occurrence of public heath emergencies.

Article 3 The State Food and Drug Administration may, according to law, decide to follow the Procedure to conduct special review and approval of drugs for public health emergencies in any of the following circumstances:

(1) Where the President of the People’s Republic of China declares a state of emergency or the State Council decides that certain areas within a province, autonomous region or municipality directly under the Central Government are in a state of emergency;

(2) Where the contingency program for public health emergencies is initiated according to law;

(3) Where the drug reserve department or the health administrative department of the State Council proposes a special review and approval for drugs having existing national drug standard;

(4) Other circumstances applicable to special review and approval.

Article 4 The State Food and Drug Administration is responsible for the review and approval of clinical trials, production and importation of drugs for the prevention and treatment of public health emergencies.

The (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government shall, upon entrustment of the State Food and Drug Administration, be responsible for on-site inspection and sampling of the pilot products of the drugs for the prevention and treatment of public health emergencies.

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CFDA Minister Zhang Yong meets UNIDO Director General Li Yong

On September 4, 2014, Zhang Yong, Minister of China Food and Drug Administration (CFDA), met with the delegation led by Li Yong, Director General of the United Nations Industrial Development Organization (UNIDO). Both parties had in-depth discussions on topics of common interest about food safety, drug supervision, inclusive and sustainable industrial development. Main directors of CFDA’s Department of International Cooperation, Department of Food Safety Supervision I, Department of Food Safety Supervision III, and relevant directors of Department of Drug and Cosmetics Supervision attended the meeting.

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